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The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period limb movements during sleep.

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Ages Eligible for Study:

18 Years to 79 Years (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion criteria:

provided written informed consent.

Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 20 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale.

Have evening and nighttime symptoms of RLS, significant sleep impairment due to RLS symptoms, and symptoms requiring treatment prior to bedtime, but no earlier than 5:00PM.

Sleep efficiency <85% OR Latency to persistent sleep >20 minutes.

Exclusion criteria:

Secondary RLS

Primary sleep disorder

Have any medical conditions that may impact efficacy assessments or that may present a safety concern.

Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control.